FDA.reportPublic FDA data

Two Striper

Primary DI
B868CFMPSKT00020
Brand
Two Striper
Company
ABRASIVE TECHNOLOGY, INC.
Model
FULL LUMINESCENCE DIAMOND POLISHING
Catalog number
CFMPSKT0002
Device description
Diamond Polishing Gel
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B868CFMPSKT00020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054028295
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B868CFES00171Two Striper379-023SCCFES00172025-09-01
B868CFES00181Two Striper379-023FCFES00182025-09-01
B868CDCP00011Prodia Carbides2CDCP00012026-05-06
B868CDCP00021Prodia Carbides2CDCP00022026-05-06
B868CDCP00031Prodia Carbides4CDCP00032026-05-06
B868CDCP00041Prodia Carbides4CDCP00042026-05-06
B868CDCP00051Prodia Carbides6CDCP00052026-05-06
B868CDCP00061Prodia Carbides6CDCP00062026-05-06
B868CDCP00071Prodia Carbides245CDCP00072026-05-06
B868CDCP00081Prodia Carbides245CDCP00082026-05-06
B868CDCP00091Prodia Carbides330CDCP00092026-05-06
B868CDCP00101Prodia Carbides330CDCP00102026-05-06
B868CDCP00111Prodia Carbides557CDCP00112026-05-06
B868CDCP00121Prodia Carbides557CDCP00122026-05-06
B868CDCP00131Prodia Carbides331CDCP00132026-05-06
B868CDCP10011Prodia Carbides7378CDCP10012026-05-06
B868CDCP10021Prodia Carbides7379CDCP10022026-05-06
B868CDCP10031Prodia Carbides7404CDCP10032026-05-06
B868CDCP10041Prodia Carbides7406CDCP10042026-05-06
B868CDCP10051Prodia Carbides7408CDCP10052026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMICESA01Ena ShinyMICERIUM SPAEJR2025-11-07
EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
00190707191177Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
07615208479195VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479201VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
TQ26126191191Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191201Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191221Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191231Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191251Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191261Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191271Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191281Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191291Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191301Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191321Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191331Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191341Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191351Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191361Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31